9 recent drug, device recalls

Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Here are nine reported to the FDA since the end of March:

  1. 200,000 acetaminophen bottles in Humana health kits recalled
    Nearly 200,000 bottles of acetaminophen in health kits distributed by Humana have been recalled.

  2. Medtronic recalls several defibrillators due to risk of shortened battery life
    Medtronic has recalled its Evera, Viva, Brava, Claria, Amplia, Compia, and Visia defibrillators, as well as its cardiac resynchronization therapy device, due to an unexpected and rapid decrease in battery life.

  3. Smisson-Cartledge Biomedical recalls IV fluids device
    Smisson-Cartledge Biomedical has recalled its ThermaCor Disposable sets, a fluid delivery device for IV bags, after finding part of the device may leak aluminum into the fluids and expose patients to high levels of the metal.

  4. Medtronic recalls thoracic stent graft system
    Medtronic has recalled the Valiant Navion thoracic stent graft system — which is used to repair lesions in the thoracic aorta, the body's largest artery — due to stent fractures and endoleak concerns. There have been 11 reported issues related to the device, including two injuries and one death.

  5. Apotex recalls ADHD drug
    Apotex has recalled three lots of guanfacine extended-release tablets after finding one of the lots contained trace amounts of a schizophrenia drug.

  6. Zydus Pharmaceuticals recalls herpes drug
    The Pennington, N.J.-based drugmaker has recalled four lots of acyclovir sodium injection after receiving several complaints of crystallization in the vials.

  7. Alembic Pharmaceuticals recalls blood pressure drugs
    Bridgewater, N.J.-based drugmaker Alembic Pharmaceuticals has recalled one lot of telmisartan tablets after finding a bottle was mislabeled as containing 20 milligrams dose pills when it actually contained 40 milligrams pills.

  8. BD updates recall of ChloraPrep applicator
    Becton, Dickinson and Company said it's determined that if its ChloraPrep 3 mL applicator device is stored in regions of the world with high heat and humidity and is exposed to temperatures beyond 86 degrees Fahrenheit and 75 percent relative humidity, it could allow the growth of Aspergillus penicillioides, a type of fungus.

  9. Medtronic recalls oxygenator and venous reservoir
    Medtronic has recalled its Affinity Pixie oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface — devices used in newborns, infants and small pediatric patients during cardiopulmonary bypass — after finding potentially elevated levels of harmful bacteria called endotoxins.

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